KH
CSV Lead / Manager
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Manager or above
5 months ago
- GxP
- Veeva
- Argus
5 months ago
- Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements.
- The role focuses on driving validation strategy, closing compliance gaps, supporting audit readiness, and overseeing validation activities across multiple enterprise systems while leading a team.
Roles & Responsibilities:
- Lead and enhance the Validation / CSV program.
- Assess gaps in current validation processes and drive remediation roadmap.
- Prepare for FDA audits and support inspection readiness activities.
- Oversee validation activities across systems including Veeva, TMF, Argus, and Serialization platforms.
- Lead and manage a small team executing CSV activities.
- Operate at both strategic and execution levels to ensure effective validation and compliance.
Experience:
- 12+ years of experience in GxP CSV / Validation.
- Strong experience in FDA audit support and inspection readiness.
- Hands-on experience with SaaS validation platforms (e.g., Veeva).
- Ability to work at both strategic and execution levels.
CSV Lead / Manager · Katalyst Healthcares & Life Sciences